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510(k) K093706

PROXISCAN MODEL 101 by Hybridyne Imaging Technologies, Inc. — Product Code IYX

K093706 is an FDA 510(k) premarket notification submitted by Hybridyne Imaging Technologies, Inc. for the device "PROXISCAN MODEL 101". The FDA issued a decision of Substantially Equivalent on April 2, 2010. The device falls under product code IYX (Camera, Scintillation (Gamma)), a Class I device regulated under 21 CFR 892.1100.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2010
Date Received
December 1, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Scintillation (Gamma)
Device Class
Class I
Regulation Number
892.1100
Review Panel
RA
Submission Type

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FDA data resources